Absolute Bioavailability and Metabolism Study of CORT118335 in Healthy Male Participants

Healthy Clinical Trial

Official title:

An Open-label, 2-part Study Designed to Assess the Absolute Bioavailability of CORT118335 and Determine the Mass Balance Recovery, Absorption, Metabolism and Elimination, and Metabolite Profile and Identification of Metabolite Structures of [14C]-CORT118335 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03878264
• Other study ID #: CORT118335-851
• Secondary ID: 2018-001507-36
• Status: Completed
• Phase: Phase 1
• Start date: August 6, 2018
• Est. completion date: March 24, 2019

Study information

• Verified date: June 2019
• Source: Corcept Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the absolute bioavailability of CORT118335 and determine the mass balance recovery, absorption, metabolism and elimination, and metabolite profile and identification of metabolite structures following a single oral dose of CORT118335 in healthy male participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 24, 2019
• Est. primary completion date: March 24, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18 to 65 years of age for Part 1 and 30 to 65 years of age for Part 2

• Body mass index of 18.0 to 30.0 kg/m^2

• Provide written informed consent

• Have regular bowel movements (i.e. average stool production of =1 and =3 stools per day) for Part 2

• Adhere to the contraception requirements.

Exclusion Criteria:

• Have received any investigational medicine in a clinical research study within the previous 3 months or CORT118335 at any time

• Employees or immediate family members of employees of the study site or Sponsor

• Have a pregnant partner

• History of abuse of any drug or alcohol, or regularly consume more than 21 units alcohol/week

• Smokers or users of e-cigarettes and nicotine replacement products within the last 6 months

• Occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017; greater than background radiation exposure from other sources exceeding 5 milliSieverts (mSv) in the last 12 months or 10 mSv in the last 5 years

• Clinically significant abnormal results of clinical laboratory safety tests, electrocardiogram, or measurement of heart rate and blood pressure

• History of clinically significant cardiovascular, renal, hepatic, endocrine, metabolic, respiratory, neurological, or gastrointestinal disease

• History and/or symptoms of adrenal insufficiency or any condition that could be aggravated by glucocorticoid blockade (e.g., an autoimmune disease; allergy requiring treatment)

• Donation or loss of greater than 400 mL of blood within the past 3 months

• Has consumed liquorice or other glycyrrhetic acid derivatives regularly in the past 6 months

• Are taking, or have taken, any prescribed, over-the-counter drug or vitamins/herbal remedies within 14 days (longer restrictions apply for some medicines).

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• CORT118335 Oral
CORT118335 900 mg spray-dried dispersion in bottle and vehicle for oral administration
• 14C-CORT118335 intravenous
14C-CORT118335 solution for infusion 100 µg containing not more than 37 kiloBequerel (1 µCi) 14C
• 14C-CORT118335 oral
14C-CORT118335 oral solution 150 mg containing not more than 3.3 megaBequerel (90 µCi) 14C

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences	Ruddington	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Corcept Therapeutics

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Oral Bioavailability (F) of CORT118335		Predose and at pre-specified time points up to Day 12
Primary	Mass Balance Recovery in Excreta After a Single Oral Dose of 14C-CORT118335		Until the mass balance criteria have been met by all participants (estimated Day 17)
Primary	Mass Balance Recovery in Urine After a Single Oral Dose of 14C-CORT118335		Until the mass balance criteria have been met by all participants (estimated Day 17)
Primary	Mass Balance Recovery in Feces After a Single Oral Dose of 14C-CORT118335		Until the mass balance criteria have been met by all participants (estimated Day 17)
Secondary	Pharmacokinetics (PK) of Total Radioactivity after Oral Dosing: Peak Plasma Concentration (Cmax)		Pre-dose and at pre-specified time points up to Day 15 after dosing
Secondary	PK of Total Radioactivity in Plasma after Oral Dosing: Time from Dosing to Cmax (tmax)		Pre-dose and at pre-specified time points up to Day 15 after dosing
Secondary	PK of Total Radioactivity after Oral Dosing: Area Under the Plasma Concentration-time Curve from Zero Time to Time of the Last Measurable Concentration (AUC0-last)		Pre-dose and at pre-specified time points up to Day 15 after dosing
Secondary	PK of Total Radioactivity in Plasma after Oral Dosing: Apparent Elimination Half-life (t1/2)		Pre-dose and at pre-specified time points up to Day 15 after dosing
Secondary	PK of Total Radioactivity in Plasma after Oral Dosing: Mean Residence Time (MRT)		Pre-dose and at pre-specified time points up to Day 15 after dosing
Secondary	PK of Plasma CORT118335 after Oral Dosing: Cmax		Pre-dose and at pre-specified time points up to Day 15 after dosing
Secondary	PK of Plasma CORT118335 after Oral Dosing: Tmax		Pre-dose and at pre-specified time points up to Day 15 after dosing
Secondary	PK of Plasma CORT118335 after Oral Dosing: AUC0-last		Pre-dose and at pre-specified time points up to Day 15 after dosing
Secondary	PK of Plasma CORT118335 after Oral Dosing: MRT		Pre-dose and at pre-specified time points up to Day 15 after dosing
Secondary	PK of Plasma 14C-CORT118335 after IV Dosing: Cmax		Pre-dose and at pre-specified time points up to Day 12 after dosing
Secondary	PK of Plasma 14C-CORT118335 after IV Dosing: AUC0-last		Pre-dose and at pre-specified time points up to Day 12 after dosing
Secondary	PK of Plasma 14C-CORT118335 after IV Dosing: t1/2		Pre-dose and at pre-specified time points up to Day 12 after dosing
Secondary	PK of Plasma 14C-CORT118335 after IV Dosing: Total Clearance (CL)		Pre-dose and at pre-specified time points up to Day 12 after dosing
Secondary	PK of Plasma 14C-CORT118335 after IV Dosing: MRT		Pre-dose and at pre-specified time points up to Day 12 after dosing
Secondary	PK of Total Radioactivity in Plasma after IV Dosing: Cmax		Pre-dose and at pre-specified time points up to Day 12 after dosing
Secondary	PK of Total Radioactivity in Plasma after IV Dosing: AUC0-last		Pre-dose and at pre-specified time points up to Day 12 after dosing
Secondary	PK of Total Radioactivity in Plasma after IV Dosing: t1/2		Pre-dose and at pre-specified time points up to Day 12 after dosing
Secondary	PK of Total Radioactivity in Plasma after IV Dosing: CL		Pre-dose and at pre-specified time points up to Day 12 after dosing
Secondary	PK of Total Radioactivity in Plasma after IV Dosing: MRT		Pre-dose and at pre-specified time points up to Day 12 after dosing
Secondary	PK in Plasma after IV Dosing: AUC0-last for 14C-CORT118335 / AUC0-last for Total Radioactivity		Pre-dose and at pre-specified time points up to Day 12 after dosing
Secondary	Distribution of Total Radioactivity into Red Blood Cells after Oral Dosing		Pre-dose and at pre-specified time points up to Day 15 after dosing
Secondary	Number of CORT118335 Metabolites Accounting for >10% of Total Radioactivity Detected in Plasma, Urine, and Feces		Until the mass balance criteria have been met by all participants (estimated Day 17)
Secondary	Percentage of Participants with One or More Adverse Events		Until the mass balance criteria have been met by all participants (estimated Day 17)